Although flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression can accurately rule out myelodysplastic neoplasms (MDS), it lacks reliability and efficiency due to the practical limitations of laboratory-developed liquid reagent-based assays. This study aimed to quantify the agreement and comparative discriminatory accuracy between a single-use flow cytometric lyophilised reagent tube (BD Lyotube Stain 468) and its laboratory-developed liquid reagent counterpart.

Cross-sectional diagnostic accuracy study of two index tests against a reference diagnosis.

A university hospital in France.

Consecutive adult patients with an indication for bone marrow aspiration due to suspected MDS and unexplained peripheral blood cytopenia.

MDS confirmed by cytomorphological evaluation of the bone marrow aspirate performed in duplicate by experienced haematopathologists blinded to the index test.

Of 103 participants enrolled between July 2020 and August 2021, 37 had MDS (prevalence, 36%). The median intra-individual robust coefficient of variation (RCV) for myeloperoxidase expression was 30.9% using the BD Lyotube Stain 468 and 31.2% using the laboratory-developed liquid reagent assay, with an intraclass correlation coefficient of 0.94 (95% CI 0.91 to 0.96). The areas under the receiver operating characteristic curves were 0.83 (95% CI 0.74 to 0.90) and 0.82 (95% CI 0.73 to 0.89), respectively. Using a prespecified threshold of 30.0%, the corresponding sensitivity estimates were 89% (95% CI 75% to 97%) and 95% (95% CI 82% to 99%).

BD Lyotube Stain 468 performs as well as its laboratory-developed liquid reagent counterpart for the quantification of myeloperoxidase expression by peripheral blood neutrophils. It may obviate the need for invasive bone marrow aspiration in up to 40% of patients with suspected MDS.

NCT04399018.

Pre-eclampsia and fetal growth restriction (FGR) are two principal complications of pregnancy related to placental dysfunction. Nevertheless, knowledge of the underlying pathophysiological mechanisms remains inadequate, and only a few tools are available for in vivo assessment of placental perfusion. Contrast-enhanced ultrasound (CEUS) allows organ vascularisation evaluation via a strictly intravascular gas microbubble. The primary aim of this study is to compare placental vascularisation parameters obtained via CEUS between pregnancies with FGR and those without FGR.

This is a single-centre, prospective, comparative, non-randomised, feasible, open and interventional study. We will include 30 women with medical termination of pregnancy divided into two groups: one with severe FGR and the other without FGR. Severe FGR is defined as an estimated fetal weight below the third percentile for gestational age. Women will be informed and recruited in the fetal medicine unit over a period of 48 months. The primary goal of this study is to compare the placental contrast ultrasound parameter measurements according to group. The primary objective is to compare placental contrast ultrasound data in women who undergo medical termination of pregnancy at a gestational age of 16 weeks (38+6 days) between two groups: a group with FGR and a group without FGR. The secondary objectives are as follows: (1) to describe the placental vascularisation parameters measured by CEUS; (2) to describe the parameters for quantifying vascularisation at different gestational ages via CEUS; (3) to study the associations between CEUS data and placental histological data and (4) to establish a biological collection of placentas to increase our knowledge of the development and functions of the placenta during pregnancy. The statistical analysis will include descriptive analysis for all study patients, with quantitative data described by means±SDs, medians, IQRs, and extreme values and qualitative data reported as counts and percentages. Comparisons of placental contrast ultrasound parameters between the two groups will be performed via Student’s t-test or the Mann-Whitney U test on the basis of data normality. Associations between CEUS parameters and placental histology data will be analysed with Spearman or Pearson correlations. Qualitative associations will be studied via analysis of variance or the Kruskal-Wallis test. Box plot representations will be used when applicable. Analyses will be performed with R software, with significance set at p

This study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD EST II – LYON – FRANCE, on 26 April 2024, with reference number 2023-506936-34-00, and the competent authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) authorised the study on 17 May 2024. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.

NCT06497959; EU CT number: 2023-506936-34-00.

Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst, etc). This discomfort is real and can be associated with psychological consequences. We hypothesised that the use of immersive virtual reality (IVR) with HypnoVR is feasible and can help reduce discomfort in intensive care.

The ZION trial is a prospective, monocentric trial randomising 194 patients admitted to a surgical ICU after a major surgery. The inclusion criterion is patients admitted to a surgical ICU for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR two times a day during the ICU stay (2–5 days). In the control group, postoperative care will be conducted according to standard care without IVR. The primary endpoint will be the 18-item IPREA (Inconforts des Patients de REAnimation) questionnaire on the day of ICU discharge. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnoea, thirst and sleep deprivation); the 18-Item IPREA Questionnaire assessed daily from randomisation to the V1 follow-up visit (ICU discharge); incidence of delirium; cumulative morphine consumption at ICU discharge; length of ICU stay and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.

Ethical approval was obtained from the institutional review board of the University Hospital of Amiens (Registration number ID: 2024-A01528-39) in January 2025.

NCT06830369.